Breast CancerNCT07917845
Evaluation of Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors
A study testing Massage therapy in people with Breast Cancer and Fatigue in Cancer Survivors, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to better understand how massage therapy helps reduce fatigue related to cancer and its treatment in breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Fatigue in Cancer Survivors
- What is being tested?
- Massage therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to understand and willingness to sign an IRB-approved informed consent
- Age ≥ 18 years at the time of consent
- Self-reported fatigue, as documented by the treating clinician
- Patient with stage 0 - III breast cancer actively being treated for their diagnosis
- Score of ≤ 10 on Patient Health Questionnaire-9 (PHQ-9)
- Will refrain from receiving any massage therapy treatments outside of the study for the duration of study participation
- Available for massage therapy on Mondays and Wednesdays
Who cannot join
- Any documented, clinically significant cardiac-related abnormality that would deem massage therapy unsafe as per enrolling investigator
- Participation in another clinical trial that is interventional or related to fatigue
- Already receiving massage therapy clinically and/or personally
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Atrium Health Levine Cancer
Charlotte, North Carolina, 28204
Margarita Dzhanumova, 980-442-2343, Margarita.Dzhanumova@advocatehealth.org
Dori Beeler, PhD
About this study
Official title: Mechanism Anchored Evaluation of Short Course Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors: A Waitlist Controlled Pilot Trial
The purpose of this study is to better understand how massage therapy helps reduce fatigue related to cancer and its treatment in breast cancer survivors.
Read the detailed description
The study will utilize a randomized waitlist-controlled design to assess symptomatic changes, generating mechanistic insights into MT. Participants in the intervention arm will receive a 30-minute massage twice a week, for three weeks. Waitlist participants will complete all NON-Massage Therapy study assessments during the active study phase at the same time points as the intervention group.
- Conditions
- Breast Cancer, Fatigue in Cancer Survivors
- Being tested
- Massage therapy
- Keywords
- Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Massage therapyProcedure or surgery
Massage therapy will consist of Swedish techniques modified for oncology massage, including stroking, compression, and percussion. Hands-on techniques include varied combinations of effleurage, petrissage, friction, tapotement, and vibration. Pressure is measured using the validated WPS, ranging from 1 (light) to 3 (medium), as needed. For the purposes of this study, the therapist will not exceed WPS 3, as this is generally perceive this level of pressure as pleasant and relaxing, thereby fostering trust.
| Study group | Role | What they receive |
|---|---|---|
| Massage Therapy | Experimental | During the active study phase, a 30-minute massage twice a week, for three weeks with pressure guided by the Walton Pressure Scale (WPS) and fidelity monitored using an Oncology Massage Therapy (OMT) checklist. Study assessments will also be given. Receives: Procedure: Massage therapy |
| Non-Massage Therapy | No intervention | Complete all Non-Massage Therapy study assessments during the active study phase at the same time points as the intervention group enabling comparisons of symptom change over the same period. The waitlist control arm will receive MT during the non-active study phase. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Fatigue Score
The patient-reported fatigue score, obtained from the PROMIS F-SF 7b, is a continuous variable measured on a 5-point scale (1-5), where 1 indicates never, and 5 indicates always, with a 24-hour recall. The PROMIS F-SF 7b includes 7 items that assess the participant's fatigue intensity, frequency, and interference with daily activities. Item responses are summed to generate a raw score ranging from 7 to 35, with higher scores indicating greater fatigue severity. Raw scores will be converted to standardized PROMIS T scores using the official table, resulting in T-scores ranging from 31.0 to 81.4, with higher scores indicating greater fatigue severity.
Measured: Twice weekly for 3 weeks, including baseline before massage therapy (pre-MT), and at 4 weeks post-massage therapy (post-MT)
Secondary outcomes (1)
Objective fatigue score
The objective fatigue score, obtained from the six-minute walk test (6MWT), is a continuous variable measured in meters and serves as an objective measure of fatigue and physical performance. The score reflects the distance the participant can walk in six minutes, as assessed by a trained designee. Higher values indicate better physical performance and lower levels of objective fatigue.
Measured: Twice weekly for 3 weeks, including baseline before pre-MT, and at 4 weeks post-MT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist
- Responsible party
- Sponsor
- Investigators
- Dori Beeler, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07917845
- Sponsor's protocol ID
- IRB00156517
- Other IDs
- ONC-BRST-2515
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism Anchored Evaluation of Short Course Massage Therapy for Cancer Related Fatigue in Breast Cancer Survivors: A Waitlist Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT07917845
- Acronym / sponsor ID
- IRB00156517
- Conditions
- Breast Cancer, Fatigue in Cancer Survivors
- Keywords
- Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to better understand how massage therapy helps reduce fatigue related to cancer and its treatment in breast cancer survivors.
Detailed description
The study will utilize a randomized waitlist-controlled design to assess symptomatic changes, generating mechanistic insights into MT. Participants in the intervention arm will receive a 30-minute massage twice a week, for three weeks. Waitlist participants will complete all NON-Massage Therapy study assessments during the active study phase at the same time points as the intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Massage Therapy | Experimental | Procedure: Massage therapyDuring the active study phase, a 30-minute massage twice a week, for three weeks with pressure guided by the Walton Pressure Scale (WPS) and fidelity monitored using an Oncology Massage Therapy (OMT) checklist. Study assessments will also be given. |
| Non-Massage Therapy | No intervention | –Complete all Non-Massage Therapy study assessments during the active study phase at the same time points as the intervention group enabling comparisons of symptom change over the same period. The waitlist control arm will receive MT during the non-active study phase. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to understand and willingness to sign an IRB-approved informed consent
- Age ≥ 18 years at the time of consent
- Self-reported fatigue, as documented by the treating clinician
- Patient with stage 0 - III breast cancer actively being treated for their diagnosis
- Score of ≤ 10 on Patient Health Questionnaire-9 (PHQ-9)
Key exclusion criteria (3 listed)
- Any documented, clinically significant cardiac-related abnormality that would deem massage therapy unsafe as per enrolling investigator
- Participation in another clinical trial that is interventional or related to fatigue
- Already receiving massage therapy clinically and/or personally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Massage therapyMassage therapy will consist of Swedish techniques modified for oncology massage, including stroking, compression, and percussion. Hands-on techniques include varied combinations of effleurage, petrissage, friction, tapotement, and vibration. Pressure is measured using the validated WPS, ranging from 1 (light) to 3 (medium), as needed. For the purposes of this study, the therapist will not exceed WPS 3, as this is generally perceive this level of pressure as pleasant and relaxing, thereby fostering trust. | Procedure or surgery | Massage Therapy |
Primary outcome
Patient-Reported Fatigue Score
Time frame: Twice weekly for 3 weeks, including baseline before massage therapy (pre-MT), and at 4 weeks post-massage therapy (post-MT)
The patient-reported fatigue score, obtained from the PROMIS F-SF 7b, is a continuous variable measured on a 5-point scale (1-5), where 1 indicates never, and 5 indicates always, with a 24-hour recall. The PROMIS F-SF 7b includes 7 items that assess the participant's fatigue intensity, frequency, and interference with daily activities. Item responses are summed to generate a raw score ranging from 7 to 35, with higher scores indicating greater fatigue severity. Raw scores will be converted to standardized PROMIS T scores using the official table, resulting in T-scores ranging from 31.0 to 81.4, with higher scores indicating greater fatigue severity.
1 secondary outcome
Objective fatigue score
Time frame: Twice weekly for 3 weeks, including baseline before pre-MT, and at 4 weeks post-MT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dori Beeler, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Massage therapy in people with Breast Cancer and Fatigue in Cancer Survivors, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margarita Dzhanumova (980-442-2307, margarita.dzhanumova@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Fatigue Score (time frame: Twice weekly for 3 weeks, including baseline before massage therapy (pre-MT), and at 4 weeks post-massage therapy (post-MT)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.